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- Early regulatory operations planning key to submission-ready dossiersRegulatory operations are often treated as a final step after all scientific data are compiled, but the article argues they should be integrated from the start of a development program. A dossier…
- Scholar Rock removes Indiana manufacturing site from SMA drug application after FDA cites deficienciesScholar Rock, a Massachusetts biotech, announced it is withdrawing an Indiana manufacturing facility from its filing for a prospective spinal muscular atrophy (SMA) therapy. The decision follows a…